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New treatment option for Familial Hypercholesterolemias
Official title Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
ClinicalTrials.gov ID: NCT06960902
What this study is testing
- What it's testing
- The goal of this study (interventional clinical research not involving a health product) is to assess the prevalence of subclinical coronary atherosclerosis diagnosed by coronary CT angiography in heart failure patients in primary prevention, across different levels of cardiovascular risk defined by coronary artery calcium (CAC) score percentiles (based on data from the MESA study): low risk (≤25th percentile for age, sex, and ethnicity), intermediate risk (25th \ 75th percentile). The Patients will attend an on-site visit at inclusion (and must undergo a coronary CT angiography within 6 months following this visit), will be contacted by phone at 1 year and 2 years, and will return for an on-site visit at 30 months.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Person willing to sign the study consent form
- Person affiliated with a current social security scheme
- Person with a definite diagnosis of Familial Hypercholesterolemia, defined by a Dutch Lipid Clinic Network (DLCN) clinical-biological score \> 8...
- Male aged 40 years or older, or female aged 50 years or older
- Ability to understand French for questionnaire completion
You likely can't join if
- Subject with a technical contraindication for coronary CT scan: patient diameter \> 70 cm and/or weight \> 250 kg
- Patient with a history of atherosclerotic cardiovascular event (myocardial infarction, ischemic heart disease, coronary revascularization, ischemic...
- Patient allergic to iodinated contrast agents
- Severe renal insufficiency: estimated glomerular filtration rate (eGFR) according to the CKD-EPI formula ≤ 30 ml/min
- Subject with active cancer or in remission for less than 3 years
- Subject who has received oral or intravenous corticosteroid therapy within the last 6 months
See the full eligibility criteria
- Person willing to sign the study consent form
- Person affiliated with a current social security scheme
- Person with a definite diagnosis of Familial Hypercholesterolemia, defined by a Dutch Lipid Clinic Network (DLCN) clinical-biological score \> 8 and/or an identified causal mutation in the LDL receptor (LDLR) gene...
- Male aged 40 years or older, or female aged 50 years or older
- Ability to understand French for questionnaire completion
- Person not taking any lipid-lowering medication or on a stable dose of lipid-lowering therapy for at least one month prior to inclusion (three months for PCSK9 inhibitors) at Visit 1
- Person not taking any antihypertensive medication or on a stable dose of antihypertensive therapy for at least one month at Visit 1
- Person not taking any antidiabetic medication or on a stable dose of antidiabetic therapy for at least 3 months at Visit 1
- Subject with a technical contraindication for coronary CT scan: patient diameter \> 70 cm and/or weight \> 250 kg
- Patient with a history of atherosclerotic cardiovascular event (myocardial infarction, ischemic heart disease, coronary revascularization, ischemic stroke, carotid endarterectomy, lower limb arterial revascularization)
- Patient allergic to iodinated contrast agents
- Severe renal insufficiency: estimated glomerular filtration rate (eGFR) according to the CKD-EPI formula ≤ 30 ml/min
- Subject with active cancer or in remission for less than 3 years
- Subject who has received oral or intravenous corticosteroid therapy within the last 6 months
- Subject with untreated or poorly controlled hypothyroidism
- Subject receiving immunosuppressive or anticancer therapy
- Subject refusing to participate
- Subject under guardianship, curatorship, or judicial protection, or without social insurance coverage
- Pregnant woman
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
- Lille, France
- Lyon, France
- Marseille, France
- Nantes, France
- Paris, France
- Rennes, France
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France; Lille, France; Lyon, France; Marseille, France; Nantes, France; Paris, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.